“CMS announced that it will delay the effective date of a final rule updating the definition of ‘reasonable and necessary’ and the guidelines surrounding the Medicare Coverage of Innovative Technology (MCIT) pathway. This delay is intended to give CMS time to address stakeholder issues that surfaced during its public comment period.”
“CMS originally published its final rule, titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary,’” (MCIT/R&N) in January 2021.”
“’The January 2021 final rule established a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA),’ the CMS announcement stated.”
“The rule was planned to go into effect on March 15th, but a memorandum from Ronald A. Klain, Assistant to the President and Chief of Staff, outlined President Biden’s intention to closely review all new and pending rules before implementation. In addition, the memorandum asked that agencies review all facts and legal considerations prior to submitting rules to the Office of the Federal Register.”
“Due to this announcement, CMS delayed the effective date to May 15th and opened a public comment period to address any concerns.”
“After receiving 215 responses addressing various concerns about the rule, CMS determined that it would not be feasible to implement the changes by May 15th…” Read the full article here.
Source: CMS Delays Codifying Definition of “Reasonable and Necessary” — By Jill McKeon, May 20, 2021. RevCycle Intelligence.
